Neonatal Test SolutionsNeonatal quality assurance solutions from an ISO 13485 medical device company.

The smallest patients can be at the greatest risk. The external world is very different from the safe haven of a mother’s womb. From the moment they enter the world, babies are exposed to a barrage of stimuli from ambient noise and light to temperature variations. Most babies adapt quickly, helped by radiant warmers, phototherapy, and routine moni-toring.

Other infants, especially those born prematurely, require immediate medical assistance. If born in a facility without a neonatal intensive care unit (NICU) or incubator, they might be placed in a transport infant incubator, and then moved to a children’s hospital or larger medical facility with a NICU.

Once in the NICU, these babies are placed in an in-fant incubator, which supports their growth with a carefully controlled environment aimed to replicate the womb. Temperature, oxygen, humidity, airflow, and sound are meticulously modulated to create the safest and most effective environment to heal and grow as possible. They might also be hooked up to a ventilator, cardio-respiratory monitor, IV pump, or pulse oximeter.

Because infants can’t say whether they’re uncom-fortable, having difficulty breathing, or experiencing pain, it’s important to regularly test and verify the performance and safety of the medical devices used in maternity wards and NICUs—especially because of the high sensitivity and fragility of these small patients.

Fluke Biomedical offers a range of test devices to verify neonatal medical devices are working as expected, and also meet global safety and perfor-mance standards to ensure the smallest patients have the best chance for thriving and eventually, going home.

Ensure the safety of your smallest patients

Nurturing The transition from the womb to the world can be difficult; incubators and radiant warmers are designed to be nurturing—providing a warm and protective environment. The INCU II Incubator/Radiant Warmer Analyzer is an all-in-one device designed to simplify testing and verifying the safety and performance of incubators, transport incuba-tors, and radiant warmers.

Healing Many newborns are born with high bilirubin levels in their blood, resulting in jaundice—a condition treated by phototherapy. The Dale 40 Phototherapy Radiometer reliably and accurately tests the blue part of the spectrum from 400-480 nanometers to help ensure infants are receiving the optimal levels of phototherapy.

Validating Because an infant cannot tell you what is wrong with their environment, it’s important to monitor their vital signs both before and after birth. The PS320 Fetal Simulator simplifies testing and verifying the performance of electronic monitors by simulating fetal and maternal ECG and uterine activities.

Measure and confirm the concentration of oxygen in an infant incubator with the Max O2 PLUS AE Oxygen Analyzer. This hand-held analyzer can also be used to measure the concentration of oxygen from ventilators or anesthesia systems, or a source of gas such as an oxygen tank.

ProSim 4 Vital Signs Simulator and the SPOT Light Sp02 Tester are intuitive-to-use patient monitor test tools to verify neonatal monitors are adjusted to effectively test infant vital signs.

First moments

INCU II Incubator/ Radiant Warmer AnalyzerFunctionality you need. Compactness you desire.

The Fluke Biomedical INCU II is an all-in-one incubator and radiant warmer analyzer that simplifies testing, and helps ensure the proper performance and safety of infant incubators, transport incubators, and radiant warmers.

Portable and intuitive to use, the INCU II simultaneously tests temperature, airflow, sound, and humidity. Test results and parameters can be monitored in real-time on a large easy-to-read LCD screen, or be transferred to your computer wirelessly*. A general testing option enables you to complete a quick test in just 15 minutes.

All-in-One• Simultaneously measures: – Temperature (in six different locations) – Sound – Humidity – Airflow• Can stay in incubator chamber for up to 24 hours using

rechargeable battery or 48 hours on ac power, without compromising the integrity of the test environment

Portable and easy-to-use• Portable and compact design, weighing less than 3 lb (1.4 kg)• Simplifies test set-up with color-coded temperature probes that match color of

input ports• Large, color LCD screen containing on-screen test direction, real-time data, and results

Test automation and customization• On-board test automation allows standardized work flow• Creates personalized test sequences for automatic test completion• Both standards-based testing templates and general testing options, allowing you to

create a protocol specific to your needs and complete a test in just 15 minutes

Simplifies test results, analysis, and reportingDisplays real-time test results and pass/fail indicators for fast and easy troubleshooting.

Standards-compliant• Complies with global standards, including IEC 60601-2-19, 2-20, and 2-21 for infant

incubators, transport incubators, and radiant warmers• From OEM factory floor, OEM field service, ISO field service, and in-house BMET, the

INCU II is equipped to satisfy your testing needs, including automated testing to the IEC 60601-2-19, 2-20, and 2-21 standards

*Ask your local distributor about wireless availability in your country.

Pucks included for radiant warmer temperature testing.

ProSim 4 Vital Signs Patient SimulatorQuick checks in 30 seconds

• Tests 12-lead ECG, respiration, IBM, and NIBP• Provides one-tap testing of most patient monitor checks in one minute

or less with onboard pre-sets and auto sequences • Runs all day on a single battery charge • Touchscreen technology

SPOT Light Sp02 Pulse Oximeter TesterTest in 15 seconds or less

• Lightweight, easy-to-use, with LCD display• Test any combination of saturation, heart rate, perfusion,

transmission, artifact noise, and r-curve• Rechargeable battery lasts up to 10 hours minimum• Use with the ProSim 4

At week five, a fetus’ heart starts beating, increasing to 155 to 195 beats per minute prior to birth. The strength and number of beats can be measured by a fetal electronic monitor is used to determine whether a fetus is in distress.

The PS320 Fetal Simulator mimics fetal and maternal heartbeats (ECG), along with uterine activity during labor to accurately test and troubleshoot fetal electronic monitors.

Features:

• Mechanical heart for ultrasound simulation

• TOCO simulation, external or IUP• Ultrasound simulation, including

twins• Maternal ECG simulation• Fetal ECG, tracks ultrasound #1• Internal (DECG) and external fetal

ECG• Uterine-activity selections• Fetal beat-to-beat variability

• Periodic and non-periodic fetal ECG changes

• Arrhythmia selections• Compact, lightweight, pocket-size

plastic housing• Battery operated with status

indications• Special kits available with all

required accessories and cables to test fetal monitors for specified manufacturers

PS320 Fetal SimulatorTest. Troubleshoot. Train.

Dale 40 Phototherapy RadiometerAccuracy across blue spectrum

Max O2 PLUS AE Oxygen AnalyzerPortable, on-the-go testing

The Dale 40 is used to measure light radiation in medical devices used to treat hyperbilirubinemia in newborns. It can accurately capture measurement, across the blue color spectrum from 400 to 480 nanometers.

Features:

• Intuitive to use with LCD screen• Accurate to ± 5 % of full spectral range of 429 to 472 nanometers• Measurement range of 0 to 1999 µW/cm2 with 1 µW/cm2

• Probe lens matches the cosine receiving function of human skin• Portable, weighing less than 9 ounces with a 9 V battery• Verifies output power and provides continuous measurement of

irradiation • Saves costs by eliminating premature replacement of lamps

The Max O2 PLUS AE Oxygen Analyzer measures the oxygen concentration in infant incubators, ventilators, anesthesia systems, or oxygen tanks.

Portable and straightforward to use, it can capture measurements from 0 % to 100 % with ± 3 % accuracy (actual oxygen level overfull operating range).

Features:

• One-touch calibration with reminder• Long battery life, approximately 5,000 hours• Impact resistant and drip-proof• External Max-25OE Oxygen Sensor

Instrument CarePlan

Biomedical Products

Instrument CarePlanBiomedical Products

Fluke Biomedical6045 Cochran Road Cleveland, OH 44139-3303 U.S.A.Fluke Biomedical EuropeScience Park Eindhoven 5110 5692EC Son, The NetherlandsFor more information, contact us at:(800) 850-4608 or Fax (440) 349-2307Email: sales@flukebiomedical.comWeb access: www.flukebiomedical.com

©2016 Fluke Biomedical. Specifications subject to change without notice. Printed in U.S.A. 1/2016 6007238a_en

Modification of this document is not permitted without written permission from Fluke Corporation.

Fluke Biomedical.Trusted for the measurements that matter.

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